Rosuvastatin Calcium Tablets Recalled for Manufacturing Deviations
Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for manufacturing process deviations with no reported illnesses, injuries, or hospitalizations. The hazard is compliance-related rather than a confirmed product defect.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium Tablets, USP, 10 mg, due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility, Accord Healthcare, Inc. The recall affects products distributed nationwide in the United States.
The affected products include 30-count and 90-count bottles with specific lot numbers: F2022N, F0322I, J1322H, K0222N, L2322D, and L2822J, with expiration dates ranging from August 2023 to July 2025. Product NDCs are 68788-7086-3 and 68788-7086-9.
The recalled product
- Product
- ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
- Brand
- ROSUVASTATIN CALCIUM
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Cardiovascular / Statin
- Hazard
- cgmp-deviation
- manufacturing-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- a) Lot: F2022N
- Exp. Date: 2/29/2024
- b) Lot: F0322I
- Exp. Date: 8/31/2023
- Lot: J1322H
- Lot: K0222N
- Exp. Date: 6/30/2024
- Lot: L2322D and Lot: L2822J
- Exp. Date:7/31/2025.
Distribution
Distributed nationwide across the United States.
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